Influence of Chronic Vascular Diseases on Transcranial Doppler Profiles in Critically Ill Patients

Respiration, Artificial Clinical Trial

— CritiDop  

Official title:

Influence of Chronic Vascular Diseases on Transcranial Doppler Profiles in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02898389
• Other study ID #: LOCAL/2015/LM-01b
• Status: Completed
• Start date: June 14, 2016
• Est. completion date: September 14, 2018

Study information

• Verified date: August 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to show that cardiovascular risk factors associated with the chronic elevation of arterial resistance may be associated with "false" profiles of intracranial hypertension during transcranial doppler ultrasound of the middle cerebral arteries in intensive care unit patients. A "false" profile of intracranial hypertension is defined by a high pulsatility index without any intracranial pathology.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: September 14, 2018
• Est. primary completion date: September 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for entry in the study:

• Sedated patient under mechanical respiratory assistance

Inclusion criteria for entry in group 1: the patient meets at least one of the following criteria:

• The patient is a man over the age of 50 or a woman over the age of 60

• Hypercholesterolemia (LDL > 1.6 g/L, HDL < 0.4 g/L)

• Arterial hypertension for over 10 years (treated or systolic arterial pressure > 140 mmHG)

• Type 2 diabetes for over 10 years

• Active or former smoker in the past 3 years

• History of cardiovascular event (peripheral artery disease, heart attack, stroke/transient ischemic attack over 3 months ago)

• Chronic renal insufficiency with MDRD < 30 ml/min/1.73m^2

Inclusion criteria for entry in group 2:

• The included patient is not in group 1

Exclusion Criteria:

• acute neurological disorder (brain trauma, infectious or immune meningitis, meningoencephalitis, ischemic or hemorrhagic stroke <3 months)

• pregnant woman

• person under guardianship

• prisoners

• recent carotid surgery (<1 month)

Related Conditions & MeSH terms

• Respiration, Artificial
• Sedated
• Vascular Diseases

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulsatility index on the middle cerebral arteries		Day 0
Primary	Diastolic velocity at the middle cerebral arteries		Day 0
Primary	Mean velocity at the middle cerebral arteries		Day 0